FDA.reportPublic FDA data

ibuprofen

Product NDC
37808-647
11-digit product format
378080647
Labeler code
37808
Product ID
37808-647_fdb8cf0a-b86c-4a25-bdca-36fced8cea6f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA072096
Marketing category
ANDA
Marketing start
1991-08-09
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-647-71ibuprofen1 in 1 CARTONTABLET, FILM COATED14
37808-647-71ibuprofen50 in 1 BOTTLETABLET, FILM COATED504
37808-647-78ibuprofen100 in 1 BOTTLETABLET, FILM COATED1004
37808-647-78ibuprofen1 in 1 CARTONTABLET, FILM COATED14
37808-647-85ibuprofen250 in 1 BOTTLETABLET, FILM COATED2504
37808-647-85ibuprofen1 in 1 CARTONTABLET, FILM COATED14
37808-647-90ibuprofen500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, COATED [H E B]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, COATED [H E B]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, COATED [H E B]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, COATED [H E B]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET, COATED [H E B]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, COATED [H E B]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBUPROFEN TABLET, COATED [H E B]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, COATED [H E B]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, COATED [H E B]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET, COATED [H E B]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, COATED [H E B]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, COATED [H E B]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, COATED [H E B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-647IBUPROFEN TABLET, FILM COATED [H E B]4Current NDC, Legacy NDC, 7 package rows20240415_e00acbc0-352e-4ba1-8433-18a3079f6743.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNe00acbc0-352e-4ba1-8433-18a3079f67434
310965ibuprofen 200 MG Oral TabletSCDe00acbc0-352e-4ba1-8433-18a3079f67434
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYe00acbc0-352e-4ba1-8433-18a3079f67434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-647-71378080647711 BOTTLE in 1 CARTON (37808-647-71) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1991-08-090000-00-00NoNoCurrent
37808-647-78378080647781 BOTTLE in 1 CARTON (37808-647-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1994-09-230000-00-00NoNoCurrent
37808-647-85378080647851 BOTTLE in 1 CARTON (37808-647-85) > 250 TABLET, FILM COATED in 1 BOTTLE1 bottle1997-08-200000-00-00NoNoCurrent
37808-647-9037808064790500 TABLET, FILM COATED in 1 BOTTLE (37808-647-90) 2002-06-100000-00-00NoNoCurrent